Coming from the “Continuous Improvement” mindset, I would think that the “snapshot” that EU regulatory bodies focus on is really only from a practicality standpoint. Each time the EU regulatory bodies perform an audit, they are looking for issues at that time, not necessarily from 10 years prior- though that’s not to say those documents are off limits.

As far as the philosophies go, I think that having the entire process documented with rationale is extremely important. I’m currently struggling to understand decisions that were made years ago to the process that are causing difficulties now and trying to figure out how my changes will affect those decisions and vice versa. The documentation aspect is required, but also vital to the improvement of your device. Similar to the saying that history is doomed to repeat itself, there is nothing worse than performing a ton of work only to later realize it was done before and had the same result, or even to undo work only to find the same problems.

The information cannot live in the minds of the creators of the device, it has to be written so that it can be used to improve. I think the requirement for the DHF is the better way to go to make sure companies are not hurting themselves later.